(100 days)
Pattern Scanning Laser Trabeculoplasty (PSLT) software is intended for use with the PASCAL Synthesis and PASCAL Synthesis TwinStar for procedures in trabeculoplasty in open angle glaucoma.
Pattern Scanning Laser Trabeculoplasty (PSLT) is a software option for the currently marketed PASCAL Streamline (K171488). It represents an enhancement intended to simplify the laser trabeculoplasty procedure by applying a fixed pattern of locations to the trabecular meshwork instead of a single spot. Additionally, this modification offers greater multi-functionality for the management of glaucoma. PSLT provides rapid, defined, uniform and minimally traumatic (sub-visible) computer-guided treatment with exact abutment of the patterns. The patterns readily align to the trabecular meshwork, allowing more rapid and easier applications. Once the software is enabled, the PSLT feature is always available.
The manufacturer, Topcon Medical Laser Systems, Inc., has leveraged a previous clinical study (K171488) conducted on the predicate device, PSLT for PASCAL Streamline, to support the substantial equivalence of the new devices, PSLT with PASCAL Synthesis and PSLT with PASCAL Synthesis TwinStar. This submission does not present a new study with specific acceptance criteria for a new AI/software algorithm performance assessment, but rather asserts that the performance of the new devices is similar to the predicate based on hardware similarities and shared software.
Therefore, many of the requested details about acceptance criteria and a new study proving the device meets those criteria are not explicitly provided or applicable in the context of this 510(k) summary, as it relies on equivalence to a previously cleared device. The summary emphasizes that the PSLT software feature's specifications and performance remain unchanged, and the laser modalities have similar safety and efficacy profiles.
However, I can extract information related to the previous clinical study for the predicate device (K171488), which serves as the basis for the current device's claimed safety and effectiveness.
Here's a breakdown of the requested information based on the provided text, indicating where information is not present or not directly applicable to a new performance study for the current submission:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The K171488 study defined clinical endpoints as its primary and secondary measures of success.
- Primary Endpoint: Change in Intraocular Pressure (IOP) from baseline to 1-month post-surgery, as measured by tonometry.
- Secondary Endpoint: Success at 1-month post-surgery as measured by tonometry and CLS (likely "clinical") derived parameters.
- Reported Device Performance:
- The document states: "Results of the clinical investigation support the indications for use of the PSLT with PASCAL Streamline for procedures in trabeculoplasty in patients with open angle glaucoma by achieving clinical endpoints. Therefore, the clinical study confirms that the device is safe and effective as used according to the instructions for use."
- Specific numerical results or thresholds for "achieving clinical endpoints" are NOT provided in this summary. For example, it doesn't state "IOP reduction of X mmHg was considered successful" or list the average IOP reduction observed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: A sample size of 58 eyes was used.
- Data Provenance: The study was a "prospective, randomized, controlled study." The country of origin of the data is not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable to this study. The ground truth for this clinical study was based on physiological measurements (IOP, clinical parameters) and diagnosis of open angle glaucoma, not expert interpretation of images or other data requiring multiple readers for adjudication.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This is not applicable as the ground truth was based on objective physiological measurements and predefined diagnostic criteria, not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC study was NOT done. This was a clinical effectiveness study assessing a laser treatment device, not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. The PSLT is a software option that guides a laser treatment. Its "performance" is in guiding the laser to achieve a clinical outcome in a patient, not in making a diagnostic prediction independently. The clinical study evaluated the device (laser with PSLT software) as a whole, not just the software in isolation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth was based on clinical outcomes data (change in Intraocular Pressure (IOP) and success measured by tonometry and CLS derived parameters) in patients with a diagnosis of open angle glaucoma.
8. The sample size for the training set
- This information is not provided and is likely not applicable in the context of this 510(k) submission which relies on clinical equivalence rather than a new machine learning algorithm that requires a distinct training and test set. The PSLT software applies "a fixed pattern of locations" - suggesting a rule-based or predefined algorithm rather than one that "learns" from a training set in the typical machine learning sense.
9. How the ground truth for the training set was established
- This is not applicable for the reasons stated in point 8.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.